510(k) · Cleared
ClearedUV Smart D60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
UV Smart Technologies B.V. · SCS Ultraviolet Radiation Disinfection Chamber Device
Cleared on Jan 29, 2026 as substantially equivalent to DEN230067 (Germitec, 2024) after a 274-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jan 29, 2026
- Review
- 274 days
- Class
- Class II
- Product code
- SCS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230067 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230067 Chronos®Germitec · 2024
- This deviceK251354 UV Smart D60UV Smart Technologies B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230067 | Chronos® | Germitec | 2024 | — |
| 0 (this device) | K251354 | UV Smart D60 | UV Smart Technologies B.V. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SCS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN230067 | Chronos®Summary page 5…l General Hospital 3. PREDICATE DEVICE INFORMATION Predicate Device Name Germitec Chronos Predicate Device Clearance Number DEN230067 Common Name Chronos Classification Name Ultraviolet Radiation Disinfection Chamber… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All SCS devicesSCS Ultraviolet Radiation Disinfection Chamber Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SCS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SCS
Too few SCS 510(k)s in any year since 2007 to give a median.
Recalls per year · SCS
No recall names SCS since 2007.
Adverse event reports per year · SCS
1in 2025
MAUDE reports naming product code SCS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The UV Smart D60 is indicated for use in a healthcare environment to achieve a high level disinfection (HLD) of external surfaces of Transesophageal Echocardiogram (TEE) probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251354 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251354: UV Smart D60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251354
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026